a phase 2, dose-finding, cross-over study to evaluate the effect of a nes/e2 transdermal gel delivery on ovulation suppression in normal ovulating women

Conditions: Ovulation

Summary: this is a phase 2, dose-finding, cross-over study for the purposes of evaluating the effect of a nes/e2 transdermal gel delivery on ovulation suppression in normal ovulating women.


Eligibility criteria:
inclusion criteria: * woman is between 18 and 40 years of age * has intact uterus and ovaries * has regular menstrual cycles of 25-35 days duration * able to comply with the protocol, including frequent blood sampling, and lives within the catchment area of the clinic * understands the study procedures and agrees to participate in the study by giving written informed consent * able to use non-hormonal, double-barrier contraceptives (e.g. condoms and diaphragm) with every act of intercourse, or has been sterilized with tubal ligation, or only male partner has been sterilized with vasectomy * progesterone \>10 nmol/l in at least one sample in the lead-in cycle exclusion criteria: * all contraindications to oc use including * thrombophlebitis or thromboembolic disorders * past history of deep vein thrombophlebitis or thromboembolic disorders * past or current cerebrovascular or coronary artery disease * known or suspected carcinoma of the breast * carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia * undiagnosed abnormal genital bleeding * cholestatic jaundice of pregnancy or jaundice with prior pill use * hepatic adenomas or carcinomas * woman has a history of headaches with focal neurological symptoms * known or suspected pregnancy * aged \>35 and smoker * bmi \>29 * positive urine pregnancy test at the screening or baseline visit * desired pregnancy within the duration of the study * known hypersensitivity to progestins * known hypersensitivity to estrogen * undiagnosed vaginal discharge or vaginal lesions or abnormalities * in accordance with the bethesda system of classification women with a current abnormal pap smear suggestive of high-grade pre cancerous lesion(s), including hgsil, are excluded * women with lgsil or ascus/high-risk hpv positive may participate if further evaluated with colposcopy and biopsy and no evidence of a lesion with a severity \>cin i is present and/or endocervical curettage is negative * women with a biopsy finding of cin i should have follow up for this finding per standard of care; women are excluded if treatment is indicated in accordance with other pap class systems * women with high grade dysplasia are excluded * women with low grade dysplasia or cin i interpretation on pap smear may participate based on investigator discretion in accordance with local standard of care * breastfeeding * cancer (past history of any carcinoma or sarcoma) * history of a significant psychiatric disorder, including severe depression. * chronic or acute liver or renal disease * hypertension-- controlled by medication or defined by diastolic bp 85 mm hg or systolic bp 135mm hg after 15 minutes rest * dermatitis, psoriasis or other severe skin disorder * known or suspected alcoholism or drug abuse * clinically significant abnormalities of laboratory safety tests * chronic disease or history of illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject * woman is participating or has participated in another clinical study (involving an investigational drug) within one month prior to enrollment. * use of injectable contraceptives during the previous 3 months (e.g. cyclofem) or 9 months (e.g. dmpa) * use of oral contraceptives within the past 1 month * use of concomitant drugs that may interact with the study drugs

Keywords: nes/e2 transdermal gel delivery contraception ovulation bleeding patterns